A Critique to the European Regulatory System

Journal of Ambulatory Care Management

Volumn 27, Issue 2, 2004, Pages 98-104

  Bertele', Vittorio ^a   Li Bassi, Luca ^a  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

EMEA; Public policy; Regulatory policy

Indexed keywords

DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; DRUG SCREENING; EUROPE; POLICY; REVIEW;

EID: 1642367375     PISSN: 01489917     EISSN: None     Source Type: Journal    
DOI: 10.1097/00004479-200404000-00004     Document Type: Review

References (11)

1. Bertele', V., Torri, V., & Garattini S. (1999). Inconclusive messages from equivalence trials in thrombolysis. Heart, 81, 675-676.
2. Committee for Proprietary Medicinal Products. (2000). Points to consider on switching between superiority and non-inferiority. (Document id: CPMP/EWP/482/99). Retrieved July 27, 2000, from http://www.emea.eu.int.
3. Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. Official Journal L 22 of 9.02.1965, p. 369.
4. Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of the national health insurance systems. Official Journal L 40 of 11.02.1989, p. 8.
5. Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Official Journal L 214 of 24.08.1993, pp. 001-021.
6. European Commission. (1998a). The rules governing medicinal products in the European Union: Vol. 2A. Notice to applicants. Medicinal products for human use (pp. 15-38). Luxembourg: European Communities.
7. European Commission. (1998b). The rules governing medicinal products in the European Union: Vol. 2A. Notice to applicants. Medicinal products for human use (pp. 51-72). Luxembourg: European Communities.
8. Garattini, S., Bertele', V., & Li Bassi, L. (2003a). How can research ethics committees protect patients better? BMJ, 326, 1199-1201.
9. Garattini, S., Bertele', V., & Li Bassi, L. (2003b). Light and shade in proposed revision of EU drug-regulatory legislation. Lancet, 361(9358), 635-636.
10. International Conference for Harmonization. (2000). Topic E10: Note for guidance on choice of control groups for clinical trials (Document id: CPMP/ICH/364/96). Retrieved July 27, 2000, from http://www.emea.eu.int.
11. WHO. (1986, November 21). Ottawa Charter for Health Promotion. Paper presented at the First International Conference on Health Promotion, Ottawa, Ontario, Canada (WHO/HPR/HEP/95.1). Retrieved from http://www.who.int/hpr/NPH/docs/ottawa.chapter_hp.pdf.